ERCP in Idiopathic Recurrent Acute Pancreatitis - Full Text View

Purpose

The therapeutic impact of ERCP with sphincterotomy in the management of patients with idiopathic recurrent acute pancreatitis (RAP) needs further study. The investigators conducted a single center, feasibility, randomized trial to determine 1) the role of pancreatic manometry in predicting future episodes of RAP and 2) differences in the efficacy of no, biliary (BES) or pancreatobiliary (dual) endoscopic sphincterotomy (DES).

Condition	Intervention
Recurrent Acute Pancreatitis	Procedure: Biliary sphincterotomy Procedure: Pancreatobiliary sphincterotomy Procedure: Sham


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Defining the Role of ERCP in the Evaluation and Treatment of Idiopathic Recurrent Acute Pancreatitis

Resource links provided by NLM:

Genetics Home Reference related topics: hereditary pancreatitis

MedlinePlus related topics: Pancreatitis

U.S. FDA Resources

Further study details as provided by Indiana University:

Primary Outcome Measures:

Recurrent acute pancreatitis [ Time Frame: 120 months ] [ Designated as safety issue: No ]
Patients will be followed post-ERCP for up to 10 years. The primary outcome is development of acute pancreatitis following the index ERCP, based on standard definitions.

Acute pancreatitis is defined as new onset of pancreatic-type abdominal pain with associated elevation in serum amylase or lipase > 3 times the upper limit of normal, OR radiographic findings consistent with acute pancreatitis.

Secondary Outcome Measures:

Interval development of chronic pancreatitis [ Time Frame: 120 months ] [ Designated as safety issue: No ]
Determine the incidence of chronic pancreatitis during prolonged follow-up. Chronic pancreatitis is defined as characteristic changes on cross sectional imaging (CT or MRI/MRCP) or ERP (Cambridge classification).
Secondary assessment of risk factors for developing recurrent acute pancreatitis during follow-up [ Time Frame: 120 months ] [ Designated as safety issue: No ]
A post hoc analysis will be conducted to evaluate for independent factors associated with having recurrent acute pancreatitis during follow-up


Enrollment:	89
Study Start Date:	September 1997
Study Completion Date:	October 2014
Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Biliary sphincterotomy Cutting of the biliary sphincter muscle alone	Procedure: Biliary sphincterotomy Cutting of the biliary sphincter muscle.
Active Comparator: Dual sphincterotomy Cutting of both the biliary and pancreatic sphincter muscles.	Procedure: Pancreatobiliary sphincterotomy Cutting of both the biliary and pancreatic sphincter muscles.
Sham Comparator: Sham Among patients with normal sphincter of Oddi manometry, patients will undergo no sphincterotomy (sham therapy).	Procedure: Sham No sphincterotomy is performed in patients randomized to sham with normal SOM.
Active Comparator: Biliary sphincterotomy - Normal SOM Among patients with normal SOM, patients may be randomized to empiric biliary sphincterotomy alone.	Procedure: Biliary sphincterotomy Cutting of the biliary sphincter muscle.

Detailed Description:

Patients with idiopathic RAP, defined as ≥2 unexplained (per the treating physician) episodes of acute pancreatitis (based on standard criteria) requiring hospitalization, will be prospectively enrolled. All patients will undergo ERCP with manometry, with stratified randomization based on the assessment of pancreatic basal sphincter pressure. If <40mmHg, the patient will be randomized to sham or biliary sphincterotomy (BES). If ≥40mmHg, the patient will be randomized to BES or pancreatobiliary ("dual") sphincterotomy (DES).

Patients and physicians will not be blinded to the assignment group. Patients will be followed for up to 10 years to determine 1) incidence of RAP requiring hospitalization (using standard definitions) or 2) interval development of chronic pancreatitis (CP).

Differences between patients who did and did not develop RAP during follow-up will be compared to evaluate for factors associated with AP during follow-up.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Idiopathic recurrent acute pancreatitis, defined as two or more episodes requiring hospitalization
ERCP with SOM planned

Exclusion Criteria:

Chronic pancreatitis
Pancreas divisum
Alternate etiology identified (e.g., CBD stone, IPMN)
Inability to perform pancreatic manometry
Pregnancy, age < 18, incarceration
Inability to provide informed consent

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01583517

Locations


United States, Indiana
Indiana University Health University Hospital
Indianapolis, Indiana, United States, 46202

Sponsors and Collaborators

Indiana University

Investigators


Principal Investigator:	Stuart Sherman, MD	Indiana University

More Information

Publications:

Coté GA, Imperiale TF, Schmidt SE, Fogel E, Lehman G, McHenry L, Watkins J, Sherman S. Similar efficacies of biliary, with or without pancreatic, sphincterotomy in treatment of idiopathic recurrent acute pancreatitis. Gastroenterology. 2012 Dec;143(6):1502-1509.e1. doi: 10.1053/j.gastro.2012.09.006. Epub 2012 Sep 11.


Responsible Party:	Indiana University
ClinicalTrials.gov Identifier:	NCT01583517 History of Changes
Other Study ID Numbers:	1011003897
Study First Received:	April 20, 2012
Last Updated:	October 8, 2014
Health Authority:	United States: Institutional Review Board

Keywords provided by Indiana University:


Acute pancreatitis ERCP Sphincterotomy Manometry Sphincter of Oddi dysfunction

Additional relevant MeSH terms:


Pancreatitis Pancreatic Diseases Digestive System Diseases

ClinicalTrials.gov processed this record on September 26, 2016